title: Safety and efficacy of modern insulin analogues.
abstract: BACKGROUND
  A1chieve® was a noninterventional study evaluating the clinical safety and efficacy of biphasic insulin aspart 30, insulin detemir, and insulin aspart.
  
  
  METHODS
  Korean type 2 diabetes patients who have not been treated with the study insulin or have started it within 4 weeks before enrollment were eligible for the study. The patient selection and the choice of regimen were at the discretion of the physician. The safety and efficacy information was collected from the subjects at baseline, week 12, and week 24. The number of serious adverse drug reactions (SADRs) was the primary endpoint. The changes of clinical diabetic markers at week 12 and/or at week 24 compared to baseline were the secondary endpoints.
  
  
  RESULTS
  Out of 4,058 exposed patients, 3,003 completed the study. During the study period, three SADRs were reported in three patients (0.1%). No major hypoglycemic episodes were observed and the rate of minor hypoglycemic episodes marginally decreased during 24 weeks (from 2.77 to 2.42 events per patient-year). The overall quality of life score improved (from 66.7±15.9 to 72.5±13.5) while the mean body weight was slightly increased (0.6±3.0 kg). The 24-week reductions in glycated hemoglobin, fasting plasma glucose and postprandial plasma glucose were 1.6%±2.2%, 2.5±4.7 mmol/L, and 4.0±6.4 mmol/L, respectively.
  
  
  CONCLUSIONS
  The studied regimens showed improvements in glycemic control with low incidence of SADRs, including no incidence of major hypoglycemic episodes in Korean patients with type 2 diabetes.
authors.affiliation: Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Yoo
authors.forename: Keun Yong
authors.initials: KY
authors.lastname: Park
authors.forename: Kang Seo
authors.initials: KS
authors.lastname: Park
authors.forename: Kyu Jeung
authors.initials: KJ
authors.lastname: Ahn
authors.forename: Kyung Wan
authors.initials: KW
authors.lastname: Min
authors.forename: Jeong Hyun
authors.initials: JH
authors.lastname: Park
authors.forename: Sang Ah
authors.initials: SA
authors.lastname: Chang
authors.forename: Bong Soo
authors.initials: BS
authors.lastname: Cha
authors.forename: Dong-Jun
authors.initials: DJ
authors.lastname: Kim
authors.forename: Yong Seong
authors.initials: YS
authors.lastname: Kim
authors.forename: Tae Keun
authors.initials: TK
authors.lastname: Oh
authors.forename: Suk
authors.initials: S
authors.lastname: Chon
authors.forename: Il Seong
authors.initials: IS
authors.lastname: Nam-Goong
authors.forename: Mi Jin
authors.initials: MJ
authors.lastname: Kim
authors.forename: Hye-Soon
authors.initials: HS
authors.lastname: Kim
authors.forename: Young Sik
authors.initials: YS
authors.lastname: Choi
authors.forename: You Hern
authors.initials: YH
authors.lastname: Ahn
authors.forename: Sora
authors.initials: S
authors.lastname: Lee
authors.forename: Sei Hyun
authors.initials: SH
authors.lastname: Baik
keywords: Diabetes mellitus, type 2; Insulin; Republic of Korea; Safety; Treatment outcome